What policy do we follow?

All Canadian universities and institutions that are eligible to hold research funding from the federal Tri -Council agencies (Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council and the Canadian Institutes of Health Research) must follow the guidelines of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2). The TCPS2 can be found at: http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/

The federal panel that is responsible for the Policy can be found at: http://www.pre.ethics.gc.ca/eng/index

Who sits on the OCAD U REB?

The TCPS2 mandates the composition of the Research Ethics Board. Boards are to be made up of faculty members representing the particular research areas of the university, as well as outside members (community members) and a Specialist in Ethics. At OCAD U, all faculties are represented by at least one faculty member. We also have a Graduate Student and an Undergraduate Student member. The current members can be found here (http://www.ocadu.ca/research/research-ethics-board/REB-Membership.htm)

How does the TCPS2 define research?

The TCPS2 defines research as “an undertaking intended to extend knowledge through a disciplined inquiry or systematic investigation.”

How do applications get reviewed?

Once a researcher’s application is complete, it is sent to the Board members for review on ROMEO. All applications are reviewed proportionately to the level of risk the research poses on its participants;

Where the board considers there is the potential for more than minimal risk to human participants, or in the case of vulnerable populations, a full Board Review is required. This is decided on receipt of the REB application.

In applications for research with human participants where there is minimal risk, a delegated review with a smaller number of Board members may be implemented. This also is decided on receipt of the REB application.

What defines minimal risk?

The TCPS2 distinguishes between research that is of less than minimal risk and that which is more than minimal risk. Minimal risk is defined as: “research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in those aspects of their everyday life that relate to the research” (TCPS2, Chapter 2, Section B, “Concepts of Risk and Potential Benefits”). Minimal risk research also excludes research with vulnerable groups such as the young, the elderly, those who cannot give consent and those in vulnerable circumstances.

How long does the OCAD U REB review process take? Is there a submission deadline for applications?

Review can take a minimum of twenty working days from the date of submitting a complete signed application to receiving a response. The most common reason for a delay in receiving approval is the quality of the application. For example, if an applicant has not written his/her application in lay language, if he/she has not provided sufficient detail in answering questions, or if there are inconsistencies between the information provided on the consent form and the information provided on the application itself.

Can OCAD U REB approval be granted retroactively?

There is no provision in the TCPS2 for retroactive consent. While researchers may make initial contacts with potential groups or participants before OCAD U REB approval, actual research with human participants cannot commence before OCAD U REB approval has been received. Researchers/student researchers will not be allowed to use any data collected without OCAD U REB approval in their thesis, MRP, publications, and the like. He/she also runs the risk of being in non-compliance with the University’s Integrity in Research and Scholarship Policy by failing to follow the OCAD U REB processes.

What if I need to make changes to my research after REB approval has been granted?

An amendment application must be submitted to the Board through the ROMEO Researcher Portal when any change is made to the research plans; that includes changes in recruitment, methodology, timelines, and/or location of the research.

An amendment application must also be made when there is a change in supervisors. As with the original application process, principal/faculty advisors MUST submit amendment applications on behalf of their students.

What if I need more time to complete my research but my REB approval is expiring soon?

You may request an extension of the approval by submitting an amendment application on the ROMEO Researcher Portal 15-30 days before the approval expiration. As with the original application process, principal/faculty advisors MUST submit amendment applications on behalf of their students.

What should I do if my conducting my research will take more than a year (multi-year research)?

A researcher whose project spans more than a year should indicate this in their REB application. The REB may grant multi-year approval. In the case of multi-year approval, the researcher must submit an annual report for every year that the research is active, prior to completion, through the ROMEO Researcher Portal. An annual report is REQUIRED in order for the approval to remain valid.

When is a final report necessary?

A final report must be submitted to the Board when the research is completed in order to close out the REB's monitoring activities. As with the original application process, principal/faculty advisors MUST submit amendment applications on behalf of their students.

I have REB approval from another university. Do I need OCAD U REB approval?

Yes, all research carried out by OCAD U faculty, students and staff must receive OCAD U REB approval. If the OCAD U researcher is the principal investigator, the primary application should be submitted to the OCAD U REB through the ROMEO researcher portal. If the principal investigator is from another institution, the OCAD U researcher should include the other institution’s REB approval letter in their OCAD U REB application – with prior REB approval from another institution an application may be processed through an expedited method.

Where can I learn more about the TCPS2?

The Federal Panel on Research Ethics has a detailed tutorial on their site at: http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel.

Who can I contact for more information?

What do the best applications look like?

The best applications are ones that are complete and require no or very little back and forth between the OCAD U REB and the applicant for clarifications. Applications should be written in lay language, keeping in mind that the applicant is addressing a multi-disciplinary Board. The research should be placed within the context of the research question the student is addressing. All questions on the application should be answered. All supporting documentation including questionnaires and the consent form should be reviewed by the supervisor prior to submission.

Does user testing require REB approval?

Yes. There is a common misconception that user testing is exempt from OCAD U REB review and approval because some believe that confidential information is not being collected in this activity. Nonetheless, the risk of loss of confidentiality is not the only risks with which the TCPS2 is concerned. There are other risks to consider including physical harm.

A substantial amount of design research relies on observation. Does this require OCAD U REB approval?

Under specific circumstances, OCAD U REB review is not required for research involving the observation of people in public places. Please note that in order to be exempt, all three conditions must be met:

it does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;

individuals or groups targeted for observation have no reasonable expectation of privacy; and

any dissemination of research results does not allow identification of specific individuals.

However, it is important to note that the final decision on whether or not research requires REB approval lies with the REB itself.

Is ‘Creative Practice’ exempt from OCAD U REB review?

Article 2.6 of the TCPS2 states that: “Creative practice activities, in and of themselves, do not require REB review. However, research that employs creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.” The primary purpose of the activity is what determines whether or not it is research or creative practice. The federal panel writes: “The determining factor of whether an activity is research or creative practice is its primary purpose. If the activity is being done for an artistic purpose, as a form of expression, for example, then it is creative practice, even if research methods are being used, and even if a form of knowledge is being generated. This type of activity does not require OCAD U REB review.

If the activity is being done primarily for research purposes then it is considered to be research, even if creative practice methods are being used. This type of activity requires REB review.

Creative practice that involves human participants is expected to be governed by ethical practices established within the cultural sector.

Does research involving my family members and my friends require OCAD U REB approval?

Yes.

As a graduate student, what should I consider?

Before you apply for OCAD U REB approval, you need to have an approved thesis topic and a Principal Advisor (PA). As your PA also signs off on your OCAD U REB application on ROMEO, he/she will need time to review the application with you. Please consider timelines for preparing your OCAD U REB application, its review and the possibility that you may be asked for clarifications. No research with human participants can begin prior to OCAD U REB approval.

What is the supervisor’s role in this process?

Through submission of the student’s application in ROMEO, the supervisor indicates their approval of the REB application of the student. The supervisor must provide oversight and direction throughout the life of the project. Within the on-line application, there is a section where the supervisor signs off to: confirm that they agree to provide proper supervision and ensuring that the rights and welfare of all human participants are protected; ensure that either a request for approval renewal or a final report is submitted within a year of receiving approval; and indicate have read and approved the application and proposal.

Applications received directly from students who do not have an assigned supervisor or an approved topic will be returned through ROMEO.

When is the best time in their studies for a student to submit their application?

The supervisor should ensure that the student’s OCAD U REB application is submitted at the appropriate time in the development of their research, in other words, neither too soon nor too late. If the application is made too soon, the student will not have developed their research adequately to answer the detailed questions that the application requires and will result in the OCAD U REB either turning back the application for a full revision or requiring extensive responses to questions. The role of the OCAD U REB is not to replace the role of the supervisor although the REB process may provide another focus through which the student considers their work.

If the application is submitted too late in the process, the timelines for the review become a source of stress for students.

Do students have to wait for the OCAD U REB’s monthly meeting before submitting an application? Is there a deadline for applications?

Most research and research activities carried out at OCAD University are of minimal risk. There is no deadline for submission of applications of minimal risk. Applications can be submitted anytime on the ROMEO Researcher Portal.

Only applications involving research with human participants in vulnerable circumstances or involving more than minimal risk require a full Board review. The Board meets monthly to discuss these applications. For research of minimal risk, the REB uses a delegated review process: two Board members review the application.

What should students consider in preparing an application when their research involves an industry partner?

If there will be a benefit to either the researchers or the industrial partner (beyond the benefit to the student of receiving a graduate degree, in the case of graduate students), this must be noted in answer to Question 8 on the application which, in the interests of transparency, asks about conflicts of interest.

This benefit must also be noted on the Consent Form. The REB suggests the following language:

BENEFITS TO RESEARCHERS:

As the goal of the overall project is to [FILL IN], the research has the potential to lead to profit for the researchers or the research partners, if it is commercialised.

This is another common misconception. If students are interviewing individuals for purely factual responses, REB review is not required. However if personal opinions are being sought, the student must apply for REB approval.

Please read the following excerpt from the TCPS2 states: “In some cases, research may involve interaction with individuals who are not themselves the focus of the research in order to obtain information. For example, one may collect information from authorized personnel to release information or data in the ordinary course of their employment about organizations, policies, procedures, professional practices or statistical reports. Such individuals are not considered participants for the purposes of this Policy. This is distinct from situations where individuals are considered participants because they are themselves the focus of the research. For example, individuals who are asked for their personal opinions about organizations, or who are observed in their work setting for the purposes of research, are considered participants.”

When do undergraduate students need to submit an application to the REB?

When an undergraduate student is doing research with human participants by doing independent research (i.e. an undergraduate thesis project) AND/OR is working with a vulnerable group AND/OR is working on research of MORE than minimal risk: in these cases, the student, with a faculty supervisor, submits an individual REB application submitted to the REB through ROMEO.

In the case where students are practicing, for pedagogical reasons, skills that use research methods, but are not part of a research project, ethics oversight may be delegated to qualified faculty members on the approval of the Chair or Associate Dean (in cases where there is no chair).

What is a Course-based application?

Course based application: an REB application prepared by a faculty member to cover all work by students in a course and where the proposed research is of minimal risk.

This situation applies when all of your students are doing the same research project (instructor-designed research) OR students are designing their own data collection measures but you are providing specific guidelines for recruitment, type of measurement, procedures, data storage and disposal and reporting of results (instructor-guided research).

I am teaching a graduate course that involves research activities with human participants with no results being disseminated outside the classroom. Does this require OCAD U REB approval?

Many courses focus on pedagogical learning outcomes rather than the type of independent research with which the TCPS2 is primarily concerned. Generally, the objective of this type of endeavour is to provide students with exposure to research methods in their field of study. When this involves research activities with human participants, as the course instructor, you are required to apply for REB approval using the application for ethical review of course-based research. You can receive approval for a variety of projects within a single course by applying for course-based approval. You will find the course based application in ROMEO.

I am teaching a first or second year course that involves research activities with human participants. Does this undergraduate course work require REB approval?

Given the emphasis on pedagogical learning outcomes, it is not expected that first or second year undergraduate courses will involve research or research activities with human participants.

However, an instructor/faculty member might assign, for example, a structured project where the undergraduate will carry out an interview exercise as pedagogical learning experience (for instance, interviewing persons where the topic is non-personal, but seeking information that would be normally transmitted in the course of daily life, such as work processes, areas of expertise, or use of public facilities). In such a case, research ethics oversight can be delegated to the faculty member. The faculty member would then report his/her approval of these projects to the Program Chair or Associate Dean (in cases where there is no chair), who would, in turn, report to the Chair of the REB.

I am teaching a third or fourth year course that involves research activities with human participants. Does this undergraduate course work require REB approval?

For courses in which research or research activities involving human participants are carried out for pedagogical purposes only, the human participants are among course-mates, and in which there will be no public dissemination of results and research is of minimal risk only, a course-based application prepared by a faculty member in his/her name must be submitted to the REB through ROMEO. Course-based applications may be produced by a single faculty member for use by other instructors of the same section as long as they are identified in the application.

There may be unusual cases in which a student is doing research with human participants by doing independent research AND/OR is working with a vulnerable group AND/OR is working on research of MORE than minimal risk: in these cases, the student, with a faculty supervisor, submits an individual REB application submitted to the REB through ROMEO.